Systemic Sclerosis Stem Cell Protocol
Targeted Evaluation Route for Cardiopulmonary & Microvascular Support
- Starting Price: $11,000 USD (Preliminary Planning Estimate)
- Location: Cali, Colombia
- Suggested Stay: 4 Days
- Administration: Systemic Intravenous (IV) Infusion
- Product & Dose: Umbilical Cord-Derived Mesenchymal Stem Cells (TRUSTEM BANK)
- Regulatory Status: Investigational Intervention
Important Medical Notice:
The cellular evaluation route for Systemic Sclerosis (Scleroderma) is an investigational pathway focusing on systemic immunomodulation, microvascular support, and connective tissue inflammation tracking. It must not be presented as a cure, guaranteed reversal of skin fibrosis, or an immediate substitute for prescribed immunosuppressants, vasodilators, or specialized cardiopulmonary monitoring.
Institutional Provider Details:
Legal Entity: STEM CELLS KYRON COLOMBIA SCKC
Facility Address: Calle 6 Oeste #24f-13, Cali, Colombia
Medical Director: Dr. Carlos Eduardo Rojas Martínez, MD (CEO)
Cell Processing Laboratory: TRUSTEM BANK
Clinical Patient Manager: Daniel Sanz
SCOPE OF SERVICE
(INCLUSIONS & EXCLUSIONS)
Included in the Package
- Pre-travel rheumatology history, chest CT, & echo review
- On-site medical consultation & physical examination in Cali
- Protocol-defined baseline cardiopulmonary & lab review
- Cellular product explanation & laboratory quality reports
- Systemic IV administration & post-infusion monitoring
- Medical discharge summary for your home rheumatologist
- Structured remote follow-up at Weeks 4, 14, 36, and 52
Exclusions & Out-of-Pocket Expenses
- Flights, passports, visas, lodging, & daily meals
- Local transfers, travel insurance, & emergency evacuation
- Unscripted specialty consultations or extended hospital stays
- Ongoing iloprost/prostanoid infusions or home oxygen therapy
- Emergency room care or unscripted complication treatments
- Repeat procedures or unquoted protocol adjustments
- Caregiver expenses or personal travel companions
CLINICAL ELIGIBILITY & REQUIRED DOCUMENTS
Potential Candidates for Evaluation:
Adults with confirmed Systemic Sclerosis (limited or diffuse cutaneous) seeking an investigational supportive route.
Documented disease stability, clear vascular/skin involvement baseline, and cardiopulmonary risk stratification.
Ability to provide informed consent and adhere to strict clinical follow-up protocols.
Realistic expectations acknowledging that complete resolution of skin tightness or organ involvement cannot be guaranteed.
Situations Requiring Additional Evaluation or Exclusion:
Active scleroderma renal crisis or unmanaged severe hypertension.
Advanced, decompensated pulmonary arterial hypertension (PAH) or end-stage interstitial lung disease requiring intensive oxygen therapy.
Active systemic infection, severe digital ulcers with active gangrene/osteomyelitis, or severe GI malabsorption.
Active malignancy or severe uncompensated cardiac dysfunction.
Severe unmanaged coagulopathy or pregnancy/lactation.
Detailed medical history from your treating rheumatologist, including skin involvement score (modified Rodnan skin score if available) and Raynaud’s phenomenon history.
High-Resolution Computed Tomography (HRCT) of the chest and recent Pulmonary Function Tests (PFTs with DLCO).
Recent Echocardiogram report evaluating right ventricular pressure and ejection fraction.
Complete lab panels: CBC, renal/liver function, urinalysis, ESR/CRP, and specific autoantibody panels (Scl-70, Centromere, RNA Polymerase III).
Current medication list including immunosuppressants, antifibrotics, calcium channel blockers, and ACE inhibitors.
PROTOCOL SPECS & 4-DAY TIMELINE
Cellular Product Specifications:
Cell Type: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs).
Manufacturing Laboratory: TRUSTEM BANK.
Dose & Route: Stratified dosing based on body weight and organ involvement; delivered via Systemic Intravenous (IV) Infusion.
Quality Assurance: Certified post-thaw viability, sterility, endotoxin, and mycoplasma clearance reports.
4-Day Clinical Itinerary:
Pre-Travel (1 Week Prior): Rheumatology file review, cardiopulmonary pre-selection, and budget clearance.
Day 1 (Arrival in Cali): On-site clinical evaluation, blood pressure/renal check, and baseline safety testing.
Day 2 (Procedure Day): Systemic IV infusion under continuous clinical and hemodynamic monitoring.
Day 3 (Local Observation): Vital signs tracking, renal/microvascular observation, and symptom monitoring.
Day 4 (Travel Clearance): Final medical discharge review, summary report, and authorization for return flight.
Remote Follow-Up: Scheduled remote tracking calls at Weeks 4, 14, 36, and 52.
POST-PROCEDURE RECOVERY & RISK DISCLOSURE
Post-Procedure Recovery Guidelines:
First 48 Hours: Rest, maintain warm room temperatures to prevent Raynaud’s triggers, and stay well hydrated. Monitor blood pressure closely.
First Month: Continue taking all prescribed rheumatology, blood pressure, and vascular medications without interruption unless explicitly altered by your home specialist.
General Risks and Possible Complications:
Transient low-grade fever, mild fatigue, or IV site inflammation.
Temporary blood pressure fluctuations or mild fluid shifts.
Rare infusional, allergic, or microvascular complications.
Absence of clinical benefit or financial risk.
FREQUENTLY ASKED QUESTIONS
1. Is stem cell therapy an approved cure for Scleroderma?
No. It is an investigational approach aimed at immunomodulatory and microvascular response pathways, not an approved cure.
2. Do I need to stop my ACE inhibitors or blood pressure medication?
No. It is critical to maintain all prescribed medications, especially blood pressure treatments, to protect kidney function.
3. What does the $11,000 USD starting price include?
It covers pre-travel specialist file review, medical consultations in Cali, baseline laboratory tests, cellular product, IV infusion administration, discharge report, and 12 months of remote follow-up.
4. How do you evaluate my lungs and heart before travel?
Our medical team requires a recent High-Resolution Chest CT, Pulmonary Function Tests (PFTs), and an Echocardiogram prior to issuing travel clearance.
PRE-DECISION CHECKLIST
- I understand that stem cell therapy for Systemic Sclerosis is an investigational intervention.
- I know the cell source (UC-MSCs), IV administration route, and laboratory testing standards.
- I have uploaded my chest CT, echocardiogram, PFTs, and rheumatology records for evaluation.
- I understand that I must continue taking all prescribed blood pressure and immunosuppressive medications.
- I have consulted with my home rheumatologist prior to scheduling travel.
Provide your clinical documentation for a stratified cardiopulmonary and renal evaluation assessment in Cali, Colombia.
+ (1) 305 400 1476
+ (57) 315 399 5608
